Efficacy and Tolerability of HFNC in Patients After Weaning from Mechanical Ventilation

JRCT ID: jRCTs072240109

Registered date:10/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Respiratory faiure
• Date of first enrollment: 10/02/2025
• Target sample size: 20
• Study type: Other

Intervention(s)

Patients who are on the verge of ventilator withdrawal after at least 48 hours of ventilatory management in the intensive care unit will be the study subjects, and HFNC will be used to evaluate the effectiveness and patient comfort (tolerability) of HFNC use immediately after ventilator withdrawal.
The effectiveness of HFNC treatment will be evaluated based on continuation or discontinuation of HFNC treatment, change to other methods of oxygen administration such as oxygen mask, need for reintubation, and the rate of non-invasive positive pressure ventilation (NPPV) to maintain ventilation to determine AIRVO3 TM compliance is calculated from the rate of non-invasive positive pressure ventilation (NPPV) for maintenance.
The comfort (tolerability) level is evaluated using a 5-item questionnaire ranging from 0 to 10 (0: no discomfort, 10: totally intolerable).

Outcome(s)

• Primary Outcome: Compliance with AIRVO3

Secondary Outcome

(1) Mean respiratory rate
(2) Mean value of transcutaneous oxygen saturation
(3) Average value of administered FIO2
(4) Average value of administered flow rate
(5) Average value of temperature of heating and humidification
(6) Nasal cannula size
(7) ROX index (transcutaneous oxygen saturation/FIO2/respiration rate)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients admitted to the Intensive Care Unit of Nagasaki University Hospital and under ventilatory management by an intensivist for 48 hours or longer
(2)Patients who are on schedule to be weaned off the mechanical ventilator
(3)Patients who meet the criteria for weaning from the mechanica ventilator (see below)
(4)Age: Adult patients who are at least 18 years old at the time of consent
(5)Gender: Any gender
(6)Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will or that of their family members based on a thorough understanding of the study.

Exclude criteria

(1) Patients who cannot breathe through the nose
(2) Pregnant patients
(3) Patients who do not agree to participate in the study
(4) Other patients deemed inappropriate as research subjects by the principal investigator

Criteria for weaning from ventilator
Spontaneous respiration mode
Pressure support pressure less than 5cmH20
End-Expiratory positive pressure less than 5cmH2O
With the above setting
Respiration frequency below 25 breaths per minutes
Ventilatory volume per breath over 6mL per predicted body weight
Arterial blood partial pressure of carbon dioxide below 250mmHg
After completion of sedation, patients opens eyes on verbal instruction, able to follow simple instruction, RASS score is between -1 to 0, no new arrhythmias, no excessive use of respiratory assist muscles, no seesaw breathing

Related Information

• Primary Sponsor: Araki Hiroshi
• Secondary Sponsor: Fisher & Paykel Healthcare Limited